Multi-mode pelvic exercise probe

ABSTRACT

A perineometer exercise probe for home or clinical use assesses the strength of pelvic floor muscles and provides audible, visual and tactile biofeedback signals as training aids during pelvic exercises. The exercise probe is selectively operable in a passive reaction mode, in which audible, visual and tactile biofeedback signals proportional to pelvic muscle contractions are generated, and in an active vibrating mode in which therapeutic vibrations are applied directly to internal pelvic musculature with or without co-generation of biofeedback signals proportional to the strength of pelvic muscle contractions; and in a combination of both modes simultaneously. The probe reacts the pelvic contraction forces and thus provides passive tactile feedback signals that are experienced simultaneously with audible, visual and vibration-induced tactile biofeedback signals for improving the endurance and strength of pelvic floor muscles. Biofeedback signaling is facilitated by wireless two-way communication between the probe and a portable monitor.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation-in-part of co-pending U.S.application Ser. No. 11/268,923 entitled “Perineometer with WirelessBiofeedback,” filed Nov. 8, 2005 by Craig A. Hoffman, Gerry M. Hoffmanand Michael John England.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention is related to exercise devices for rehabilitating andstrengthening the muscles of the pelvic floor, particularly thecollective group of muscles referred to as the female pubococcygeal andrelated perineal musculature.

2. Description of the Related Art

Disorders that involve the pelvic area (bladder, pelvic floor muscle,rectum and uterus) are of great concern to women and health careproviders as well. The pubococcygeal muscle or pelvic floor muscle isresponsible for holding all the pelvic organs within the pelvic cavity.The pelvic floor muscle consists of a deep muscle layer and asuperficial muscle layer that work together to keep the pelvic organshealthy and in good working order. The muscle is suspended like ahammock at the base of the pelvis and wraps around the vagina and rectumgenerally in an over-under figure “8” pattern.

The lower pelvic muscles may become damaged or weakened throughchildbirth, lack of use, aging, or as the collateral result of surgicalprocedures. One of the symptoms related to a weakening of these musclesis urinary incontinence. Other pelvic disorders include chronic pelvicpain and vulvodynia (pelvic muscle dysfunction) that are sometimesexperienced by young adult women. These disorders are caused byinvoluntary contractions (spasms) of the levator ani and perinealmuscles. This condition, sometimes referred to as vaginismus or pelvicfloor tension myalgia, is accompanied by difficult and painfulpenetration of the vagina.

Various exercise devices have been developed in an attempt to restorethe pelvic floor muscles, with the specific goal of strengthening themuscles that surround the urethra to overcome urinary incontinence inwomen. The field of pelvic muscle rehabilitation in the treatment ofurinary incontinence has its origins in the pioneering work of Dr.Arnold H. Kegel and his perineometer invention disclosed in U.S. Pat.2,507,858, issued to Dr. Kegel in 1950.

Dr. Kegel's perineometer was the first instrument to use biofeedback toobjectively assess pelvic muscle strength, both in the physician'soffice, and in daily at-home use by the patient. His perineometerconsisted of an inflatable vaginal probe connected by an air tube to anair pressure gauge whose dial was calibrated in millimeters of mercury.The device enabled a woman (and her physician) to observe the strengthand duration of her pelvic muscle contractions in order to learneffective exercise technique.

Pelvic floor exercises increase the flow of blood to this region, aswell as creating strength and tone to the muscle itself, which helpswith healthy tissue renewal. Like any other muscle within the body, thepelvic musculature benefits from pelvic floor exercises and toning on aregular basis. In keeping with the acknowledged therapeutic effects ofthis technique, improvements to perineometer devices continue to beproposed, in which the biofeedback features are enhanced. For example,U.S. Pat. No. 6,063,045 issued to Wax et al. in 2001 shows a vaginalprobe that includes an internal pressure sensor that is connected to anexternal display device via electrical conductors for monitoring thecontraction of pelvic floor muscles. Biofeedback patterns formed on thedisplay device guide the patient through an exercise routine.

More recently, an improved perineometer probe was disclosed in U.S.Published Patent Application No. 20060036188, entitled “Perineometerwith Wireless Biofeedback,” published Feb. 16, 2005 by Craig A. Hoffman,Gerry M. Hoffman and Michael John England. That invention features aself-contained perineometer probe for intravaginal use that communicatesa wireless biofeedback signal to a small hand-held controller anddisplay unit. The display unit provides audible and visual biofeedbacksignals that allow the patient to monitor her exercise efforts asself-directed or according to a prescribed training protocol, andoptionally as prompted by a pre-programmed routine contained in thedisplay unit.

Contemporary pelvic muscle training instruments are now incorporatingvibrators for applying vibratory stimulation during exercise routines.Vibratory stimulation is known to have therapeutic and beneficialeffects on human body tissue. Vibration at low frequencies applied totissue increases blood circulation due to the increase in capillarydilation. The increased blood flow increases the consumption of oxygenand nutrients by muscles and improves the regeneration process. Theresult is improved muscle tone, elasticity and contractile capacity.

An example of vibratory stimulation is given in U.S. Pat. No. 6,905,471to Leivseth et al., which discloses a pelvic exercise trainer in theform of a probe having a pressure sensor, a vibrator and amicroprocessor circuit connected to the sensor and vibrator. Thecontraction of the pelvic floor muscles is repeated at intervals, andthe force applied by pelvic floor muscles at each contraction ismeasured and compared with the highest previously registered value,which is stored in memory. The vibrator is activated at each contractiononly if the contraction force attains or exceeds the most recentregistered value, and only for as long as that relationship ismaintained, e.g., the sensed pelvic contraction force attains or exceedsat least 80% of the last registered value.

U.S. Pat. No. 5,782,745 to Benderev discloses a pelvic exercise trainerin the form of a probe having a vibrator assembly and mechanical meansfor extending and retracting the assembly for the purpose of stretchingthe pelvic muscles. The probe is operable in a minimum profile, restmode configuration where it exerts only base-line pressure, and operablein an extended profile, exercise mode configuration where it is capableof exerting higher pressure. A timer controls transitions between theoperating modes. The vibrator assembly is operable only when the probeis in the extended configuration (exercise mode).

Notwithstanding the progress made by conventional pelvic exercisedevices, there is a continuing interest in providing an improvedbiofeedback probe that can apply internal vibration therapy and iseffective for rehabilitating and strengthening the muscles of the pelvicfloor, particularly the collective group of muscles referred to as thefemale pubococcygeal and related perineal musculature. There is afurther need for a biofeedback probe that can apply internal vibrationtherapy and is effective for use by women who are experiencing painfulpelvic spasms (pelvic floor tension myalgia), as an aid for trainingpelvic muscle relaxation techniques.

SUMMARY OF THE INVENTION

The present invention provides a medical instrument in the form of aperineometer probe for training and conditioning the pelvic floormuscles, including the collective group of muscles involved in sexualresponse. The medical instrument of the present invention is selectivelyoperable in a passive, reaction mode, in which audio/visual biofeedbacksignals proportional to pelvic muscle contractions are generated, and inan active, vibrating mode in which vibration therapy is applied directlyto internal pelvic musculature with co-generation of vibration-inducedtactile biofeedback signals proportional to the strength of pelvicmuscle contractions; and in a combination of both modes simultaneously.The training instrument features a self-contained perineometer probe forintravaginal use that contains the vibrator apparatus and an RFtransmitter that communicates a wireless biofeedback signal to a smallportable transceiver and display unit. The display unit provides anaudible signal and visual display that allows a patient to monitor herefforts as self-directed or according to a prescribed training protocol,and optionally as prompted by a pre-programmed routine contained in thedisplay unit.

The invention in particular provides a perineometer probe forintravaginal use in connection with the development, training,conditioning and rehabilitation of the female pubococcygeal and relatedperineal musculature. The pelvic muscle exercising device includes aninternal vibrator that applies vibrations through the probe directly tothe pelvic floor muscles in an active exercise mode. The frequency ofthe vibration is controlled as a function of the sensed pelviccontraction pressure. The patient can select operation in three modes:active vibration only, passive reaction only (with or withoutbiofeedback signal display), and a combination of active vibration andpassive reaction.

According to one aspect of the invention, a perineometer probe containspelvic muscle contraction pressure sensing circuitry and components thatprovide audio/visual biofeedback signals, and an internal vibratordevice, for example a motor-driven vibrator or a piezoelectric vibrator,that applies therapeutic vibrations directly to the pelvic muscle inresponse to the magnitude of contraction pressure applied to the body ofthe probe while a training exercise is taking place. The vibration probeis operated via wireless transmission in association with a hand-heldmonitor where biofeedback signals are communicated audibly and visuallyfor real time observation while a training exercise is underway.

According to another aspect of the invention, a perineometer probe,operating wirelessly in association with a hand-held display unit,contains pelvic pressure sensing circuitry and a mechanical vibrator,for example a motor-driven vibrator or a piezoelectric vibrator, thatproduces therapeutic tactile vibrations while pelvic muscle exercise isunderway. According to a pelvic muscle strengthening mode of operation,the circuitry increases the vibration frequency in proportion to anincrease in the magnitude of the sensed contraction pressure. In apelvic muscle relaxation training mode of operation, the circuitryreduces the vibration frequency of vibration in proportion to areduction in the sensed contraction pressure.

Because the probe remains inserted during exercise and the reactionmember is in intimate contact with the pelvic muscles, the probe can besensed directly and felt by the patient as the pelvic muscles arecontracted against it, thus providing a passive tactile biofeedbacksignal either alone or in combination with active, vibration-inducedtactile biofeedback signals.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

FIG. 1 is a simplified sectional view of the pelvic region of the femaleanatomy, showing the perineometer probe of the present inventioninserted within the intravaginal cavity in the operative sensingposition;

FIG. 2 is a side elevational view, partly in section, of theperineometer probe of the present invention;

FIG. 2A is a front elevational view thereof;

FIG. 3 is a sectional view of the perineometer probe, taken along theline 3-3 of FIG. 2;

FIG. 4 is a perspective view of the perineometer probe of the presentinvention;

FIG. 5 is a perspective view of a transducer sleeve, shown removed fromthe perineometer probe;

FIG. 6 is a developed plan view of a polymeric composition formtransducer sleeve, shown in its flat configuration prior to assemblyonto the perineometer probe;

FIG. 7 is an enlarged sectional view of a portion of the polymericcomposition transducer sleeve, taken along the line 7-7 of FIG. 6;

FIG. 8 is a developed plan view of a textile form fabric transducersleeve, shown in its flat configuration prior to assembly onto theperineometer probe;

FIG. 9 is a peeled-away perspective view of the textile form fabrictransducer sleeve of FIG. 8;

FIG. 10 is a developed plan view of a flexible polymeric piezoelectricform transducer sleeve, shown in its flat configuration prior toassembly onto the perineometer probe;

FIG. 11 is a sectional view of the flexible polymeric piezoelectrictransducer sleeve, taken along the line 11-11 of FIG. 10;

FIG. 12 is simplified block diagram of an R.F. transceiver module thatis contained within the perineometer probe of FIG. 1;

FIG. 13 is a front elevation view of a portable monitor with RFtransceiver that receives RF wireless signals from the perineometerprobe transmitter module and provides a visual display of the pressurewaveform and audible feedback signals in response to pelviccontractions, and sends RF wireless mode selection command signals tothe perineometer probe;

FIG. 14 is simplified circuit block diagram of the portable monitor ofFIG. 13;

FIG. 15 is a diagram that illustrates use of the perineometer incombination with the portable monitor, by a patient in the preferredlithotomy position;

FIG. 16 is a developed plan view of a transducer sleeve with multiplestrip form transducer elements, shown in its flat configuration prior toassembly onto the perineometer probe;

FIG. 17 is a perspective view of the strip form transducer sleeve shownassembled on a probe;

FIG. 18 is a developed plan view of a transducer sleeve with multipleband form transducer elements, shown in its flat configuration prior toassembly onto the perineometer probe;

FIG. 19 is a perspective view of the multiple band form transducersleeve shown assembled onto a probe;

FIG. 20 is a developed plan view of a transducer sleeve with a spiralwrap transducer element, shown in its flat configuration prior toassembly onto the perineometer probe;

FIG. 21 is a perspective view of the spiral wrap form transducer sleeveshown assembled onto a probe;

FIG. 22 is a developed plan view of a transducer sleeve with multipletransducer elements arranged in a grid pattern, shown in its flatconfiguration prior to assembly onto the perineometer probe;

FIG. 23 is a perspective view of the grid form transducer sleeve shownassembled onto a probe;

FIG. 24 is a side elevational view, partly in section, of a wirelessperineometer probe having an inflatable transducer sleeve according toan alternative embodiment of the present invention;

FIG. 25 is a sectional view thereof, taken along the line 25-25 of FIG.24;

FIG. 26 is a perspective view of the inflatable transducer sleeve shownin FIG. 24;

FIG. 27 is a circuit diagram of a piezoelectric transducer contained inthe transducer module of FIG. 24;

FIG. 28 is a rear perspective view of a multimode perineometer probewhich incorporates an internal vibrator assembly according to analternative embodiment of the invention;

FIG. 29 is a front perspective view thereof;

FIG. 30 is a sectional view thereof, taken along the line 30-30 of FIG.31;

FIG. 31 is a front elevational view thereof;

FIG. 32 is simplified circuit diagram of an R.F. transceiver andvibrator module that is contained within the multimode perineometerprobe of FIG. 28; and

FIG. 33 is a simplified graphical plot which illustrates a proportionalrelationship between vibrator RPM and pelvic contraction pressure, asrepresented by the driving voltage V_(D).

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION

The specification that follows describes the preferred embodiments withreference to portions of the female pelvic anatomy that are shown inFIG. 1, and with reference to the lithotomy position indicted in FIG.15. The perineometer probe 10 of the present invention is inserted inthe vaginal cavity 12 while the patient is reclining in the slightlyelevated lithotomy position. In that position, the patient is lying onher back, knees raised, with her head slightly elevated relative to thepelvic region. Her torso is on an approximate 30 degree angle withrespect to horizontal, which results in a half-sitting position, whichis the preferred position for pelvic exercise training.

Referring now to FIG. 1 and FIG. 15, the perineometer probe 10 ispositioned within the vaginal cavity 12 for reacting pressure forcesapplied by pelvic muscle contractions. The lower wall 14 and the upperwall 16 of the vagina are connected to muscles, tissues, and nerves,that are indicated generally at 18, 20, and collectively referred toherein as the pubococcygeal and related perineal musculature. FIG. 1also shows the uterus 22, which has an internal void known as theuterine body cavity 24, the cervix 26, the external os 28, which is theexternal opening of the cervix facing the vaginal cavity 12.

Other portions of the female anatomy shown in FIG. 1 include the bladder30, ureter 32, the urethra 34, the labium minus 36, the labium majus 38,which join together in the region adjacent the clitoris 40, near thevaginal introitus 42, all clustered about the region generally known asthe perineum 44.

Referring now to FIG. 2 and FIG. 4, the perineometer probe 10 includesan elongated body portion or shaft 46 that is terminated on its distalend by a slightly enlarged and rounded head portion 48, and on itsproximal end by a handle 50, which also functions as a closure cap. Thehandle 50 is fitted with threads 52 engaging mating threads 54 that areformed on the proximal end of the probe body. The interface between thehandle and the probe body is sealed by an O-ring seal 56.

As the patient is resting in the elevated lithotomy position shown inFIG. 11, the patient grasps the probe handle end 50 with her fingers.The patient then inserts the head 48 of the probe through the vaginalintroitus 42 and into the vagina until the probe 10 is fully inserted,with the handle 50 engaging substantially flush against the labium minus36. Upon full insertion, the probe head 48 extends into the vaginalcavity 12. The lower and upper vaginal walls 14, 16 close against theelongated body portion 46 to positively hold the probe 10 within thevaginal cavity.

The proximal end 58 of the elongated shaft portion 46 is adapted to seatat the introitus 42 of the vagina. The head portion 48 of the probe bodyis adapted to seat within the pelvic cavity 12. In the embodiment shownin FIG. 4, the head 48 is characterized by a sloping retainer surface 60that transitions smoothly from the shaft portion 46 along an outwardlyflared, conical profile until it reaches an annular rim portion 62 atthe limit of the outwardly flared profile. The head portion 48 thentransitions smoothly from the annular rim portion 62 along a roundedportion 64 having an inwardly sloping surface 66 that forms a taperedprofile. The tapered portion is terminated on the distal end by arounded nose portion 68, which facilitates insertion.

Referring to the alternative embodiment shown in FIG. 28, FIG. 29 andFIG. 30, the probe 400 has a consistent diameter along it's entire shaftlength.

In each probe embodiment, a pressure transducer sleeve 70 is fittedaround the shaft portion 46 for sensing and providing an indication ofpelvic muscle contraction pressure. As shown in FIG. 3 and FIG. 5, thetransducer sleeve 70 contains a variable impedance element 71 capable ofexhibiting a change in electrical impedance in response to changes inthe amplitude of pressure forces applied to the transducer sleeve.

The variable impedance element 71 is distributed around and generallyuniformly throughout a substantial portion of the sleeve and issandwiched between first and second conductive electrodes 73, 75 whichare disposed in electrical contact with the variable impedance element.Preferably, the conductive electrodes are formed by depositingmetallization layers of a conductive metal, for example silver, onopposite side surfaces of the impedance element 71. A base layer 77 of adielectric insulating material is applied to the external side surfaceof the first conductive electrode 73, and an outer layer 79 of adielectric insulating material is applied to the external side surfaceof the second conductive electrode 75.

According to this probe configuration, when the pelvic floor muscles 18,20 contract against the probe, the enlarged head portion 48 produces adifferential contact zone of engagement in which the pressure forces ofpelvic contraction are concentrated primarily along the externallyfacing contact surface 72 of the transducer sleeve 70. This clampingaction creates a tight banding of pelvic muscle tissue around thetransducer sleeve 10. The compressed muscle tissues 18, 20 engageagainst the flared retainer surface 60 of the head portion, whichopposes expulsion of the probe from the vagina while a contraction isunderway.

The shaft portion 46 is preferably in the form of a tubular sidewall 74that surrrounds an internal pocket 76. The distal end of the pocket 76is sealed by the head portion 48 which forms the distal boundary of thepocket. A battery module 78, providing a supply potential E, forexample, of 6 volts DC, and a signal processor circuit module 80 arereceived in tandem alignment within the pocket 76.

A conductive DC supply input terminal 82 is mounted in the pocketbetween the probe head portion 48 for electrical contact engagementagainst the negative terminal (−) of the battery module. The distal endof the signal processor circuit module 80 is fitted with a conductive DCsupply input terminal 84 for making electrical contact against thepositive terminal (+) of the battery module 78. The distal end of thesignal processor circuit module 80 is also fitted with a conductive DCsupply input terminal 85 for connection to the negative supply inputterminal 82. A conductive interconnect portion 86, connected to thenegative supply input terminal 82, extends along the tubular sidewall 74of the shaft 46 into electrical contact engagement against the negativesupply input terminal 85 of the transmitter module 80.

The proximal end of the signal processor circuit module 80 is fittedwith an RF output terminal 88 for making electrical contact against anantenna input terminal portion 90 of a dipole antenna 92 that isencapsulated within the handle 50. The RF output terminal 88 engages theantenna input terminal 90 and establishes firm electrical contact whenthe handle 50 is tightly sealed against the probe body 46. Theelectrical contact terminals are also brought into electrical contactengagement with the battery electrodes and complete a series electricalcircuit when the handle 50 is tightly sealed against the probe body.

According to one aspect of the invention, ON/OFF control of the DCsupply voltage is provided by a bias spring 94 acting in cooperationwith the handle 50. The spring 94, preferably a Belville spring washer,is interposed between the DC battery module 78 and the signal processorcircuit module 80 for urging the circuit module for movement away fromelectrical contact engagement with the positive terminal of the DCbattery module. According with this arrangement, the handle 50 isdisposed in threaded engagement with the shaft portion and engagesagainst the circuit module 80 for moving the module axially through thepocket 76 against the bias force of the spring 94.

This spring bias action allows the DC voltage input terminal 84 of thetransmitter module to be moved into and out of electrical contactengagement with the positive output terminal of the battery in responseto clockwise and counter-clockwise rotation of the handle 50 relative tothe shaft 46, thus making contact with the battery module and completingthe DC supply circuit when the probe is activated ON, and breakingcontact with the battery module and interrupting the DC supply circuitwhen the probe is turned OFF. The bias force of the spring 94 alsomaintains the RF signal output terminal 88 of the signal processorcircuit module 80 in signal contact engagement with the RF signal inputterminal 90 of the antenna 92 when the handle 50 is tightly sealedagainst the probe body.

The probe body 46, head portion 48 and handle 50 are fabricated from aninjection moldable polymer material, preferably medical grade polymerresin that is a dielectric or electrically non-conductive, for exampleacrylic resin. The internal conductor terminals 82, 84, 86 and 90 aremade of a flexible carbon impregnated conductive polymer compositionwhich may be, for example silicone polymer. The external contactsurfaces of the probe 10, including the transducer sleeve 70, arecovered by a biologically inert coating layer 96 of a seamless medicalgrade silicone elastomer, which is preferred because of its highbiocompatibility.

The silicone elastomer coating layer 96 transmits the pelvic pressurefaithfully and its performance is temperature independent. Because thecoating layer 96 is seamless and smooth, there are no joints or crevicesto trap contaminants. Preferably, the coating layer 96 should be in therange of about 1/17 inch- 7/16 inch of a compressible elastomermaterial, which will allow shortening of the muscle fibers to inducemuscle cell hypertrophy (increased muscle mass).

Referring now to FIG. 6 and FIG. 7, a variable impedance signal Z isconducted on signal conductors 98, 99 that are attached to the signaloutput nodes of a transducer 100. The impedance signal Z is proportionalto pressure forces applied during contraction of the pelvic floormuscles 20, 22. This feedback signal is developed by a sensing body inwhich the variable impedance element is provided by commerciallyavailable transducer materials.

According to a first transducer embodiment, shown in FIG. 6 and FIG. 7,the sensing body of the transducer sleeve 100 is formed by acompressible body 102 of an insulating or weakly conductive polymercomposition containing a dispersed matrix of particles 104 of at leastone strongly conductive material selected from the group consisting ofmetals, alloys and reduced metal oxides, and first and second conductiveelectrodes 106, 108 disposed in electrical contact with the polymercomposition. The conductive electrodes are covered by coating layers110, 112 respectively, of a dielectric insulating polymer composition,preferably medical grade polymer resin that is a dielectric orelectrically non-conductive, for example acrylic resin.

According to another transducer embodiment, shown in FIG. 8 and FIG. 9,the sensing body of a pressure transducer 120 is provided by a textileform variable resistance element 122 interleaved with textile formconductive members 124, 126. The variable resistance element andconductive members are enclosed between textile form non-conductive baseand covering layers 128, 130. The textile layers are formed of wovennylon or polyester yarns. The conductive members are formed by printingthe facing surfaces of the covering layers 128, 130 with deposits ofconductive inks or polymer pastes containing metals, metal oxides orsemi-conductive materials such as conductive polymers or carbon.

Preferably, the variable impedance element 122 exhibits quantumtunneling conductance when deformed. This is a well known property ofpolymer compositions in which a filler selected from powder-form metalsor alloys, electrically conductive oxides of such elements and alloys,and admixtures thereof with a non-conductive elastomer. The filler isdispersed within the elastomer and remains structurally intact and thevoids present in the starting filler powder become infilled withelastomer and particles of filler become set in close proximity duringcuring of the elastomer.

According to yet another embodiment, shown in FIG. 10 and FIG. 11, thesensing body of a pressure transducer 140 is a multi-layer flexiblelaminate comprising a base contact layer 142 of a flexible,non-conductive sheet material, for example, Mylar™ polyester film, amiddle polymeric piezoelectric sheet 144 having moralized coating layers146 and 148 on either side thereof, and an outer contact layer 150 of aflexible sheet material, for example, Mylar™ polyester film.

Preferably, the polymeric piezoelectric sheet 144 is a film ofpolyvinylidene fluoride (PVDF), a fluoroplastic resin that iscommercially available as pellets for extrusion and molding. PVDF filmis known to possess piezoelectric characteristics in its beta phase.Beta-phase PVDF is produced from ultra pure film by stretching it duringextrusion. Both surfaces of the film extrusion are then moralized, andthe film is subjected to a high voltage to polarize its atomicstructure. When compressed or stretched, the polarized PVDF filmgenerates a voltage across the moralized surfaces, in proportion to theinduced strain.

The electrical equivalent or characteristic impedance Z of thepiezoelectric film element 144 is a voltage source in series with acapacitance. The voltage source is the piezoelectric generator itself,and this source is directly proportional to the applied stimulus(pressure or strain). The transducer output voltage will absolutelyfollow the applied pressure, and the output voltage is then buffered,filtered and scaled in the signal processor module 80 before it isconverted to a digital data feedback signal.

The polyester film layers 142 and 150 are adhesively attached to themetallized coating layers 146, 148 respectively. Additionally, the baselayer 142 is adhesively bonded to the probe shaft 46. The piezoelectricmaterial 144 is preferably a layer of polarized polyvinylidene fluoride(PVDF) film sandwiched between the moralized coating layers 146, 148 ofelectrically conductive metal. Preferably, the polymeric piezoelectricsheet 144 is approximately 28 microns in thickness, and the metallizedcoating layers 146, 148 are silver deposits of about 0.1 microns inthickness.

Referring again to FIGS. 4 and 5, the pressure transducer is formed byrolling a rectangular swatch of one of the transducer embodiments 100,120 or 140 described above to produce a tubular sleeve 70 having anannular transducer body. The transducer swatch is provided in a lengthdimension approximately equal to the load surface length L of the probeand a width W approximately equal to the O.D. circumference of thetubular shaft sidewall 74. The transducer swatch is then rolled andadhesively bonded onto the tubular housing 64.

According to an alternative embodiment, the transducer swatch is rolledinto tubular sleeve form, forming an annular body 70 as indicated inFIG. 5, and the proximal end of the probe is then inserted into thesleeve and sealed. Optionally, the transducer sleeve 70 can be moldedonto the tubular sidewall 64 where a polymeric transducer material isselected.

The transducer sleeve 70 has an extended pressure-responsive area 72that is substantially coextensive in length with the run of the pelvicfloor muscles 18, 20. Consequently, when the probe 10 is fully insertedwith the handle 50 engaging the labium majus 38, the pressure responsivearea will span the pelvic floor muscles of most adult women.

Preferably, the transducer sleeve 70 is attached to the probe sidewall46 by an adhesive deposit. Excellent coupling is obtained throughadhesive attachment using pressure sensitive adhesive supplied by 3MCorporation, such as Product No. Y-9485. The adhesively coupledtransducer sleeve 70 provides high transducer sensitivity, lowmechanical and acoustic impedance to produce accurate transducer outputsignals throughout a broad range of loadings. The flexible transducersleeve 70 provides a linear voltage output for a given force, enablingthe sensing of movements as low as respiration and pulse. Moreover,because of the toughness and flexibility of the polymeric materials, thetransducer sleeve 70 is resistant to breakage caused by rough handling.

As indicated in FIG. 12, the tubular shaft 46 serves as a reaction coremember that supports the transducer sleeve 70 and reacts compressionloading applied during contractions of the pelvic floor muscles 18, 20.As the pelvic floor muscles contract, the transducer sleeve 70 isstressed in accordance with changes in applied loading and yields avariable impedance output signal Z in accordance with the changes, whilethe support shaft 46 reacts the compression forces and provides tactilesensory feedback directly to the patient.

Referring now to FIG. 12, the variable impedance signal Z is input tothe signal processor circuit module 80 via conductors 98, 99 that areelectrically connected to the metallization deposit layers of thetransducer. The signal processor circuit module 80 is a multiplefunction circuit that includes a low noise amplifier 160, ananalog-to-digital converter (ADC) 162, and an RF transmitter-receiver(transceiver) 164. The analog impedance signal Z from the transducersleeve 70 is first buffered, filtered and amplified by the low noiseamplifier 160, and then converted to a digital data signal by theanalog-to-digital converter (ADC) 162. Preferably, the components of thesignal processor circuit module 80 are implemented by conventional RFintegrated circuit (RFIC) technology.

The digitized feedback signal is input to the RF transmitter-receiver(transceiver) 164 which is operable in any frequency band which isdedicated for scientific and medical purposes. The preferred poweroutput is 25 milliwatts (nominal) at 915 MHz (North America); 868 MHz(Europe); or other frequency bands that are set aside for industrial,scientific and medical applications, for example, 433 MHz, 2.4 GHz or 5GHz bands. By this arrangement, the transmitted signal has an effectiverange of about 2 meters, which provides sufficient signal strength forreliable reception by a hand-held monitor 170.

Referring now to FIG. 13 and FIG. 14, a battery-powered, hand-heldmonitor 170 which includes an RF transceiver 174 that sends and receiveswireless feedback signals 176 to and from the probe 10 via an internalantenna 178. The wireless feedback signals are fed into a display driver180 that provides feedback data signals 182 to an audio and visualindicator 184. The indicator provides a graphic visual presentation of apelvic contraction, for example the waveform 186 and audio outputsignals 187 in response to pelvic contractions.

The monitor 170 may also be configured to display other data, such asintravaginal temperature, for example, 98.4° F.; the elapsed time ofpelvic contraction, for example E5 (5 seconds); and the numericalpressure tension value of the contraction strength in cm water, forexample P10 (10 cm water). Negative values of pelvic tension pressure(relative to the nominal “at rest” pelvic tension level) can also bedisplayed when the probe is used to monitor relaxation trainingexercises for treatment of pelvic muscle spasm disorders. Preferably,the displayed pressure tension value and the waveform are updated tentimes or more per second during contractions.

The visual display presentation is implemented by a conventional liquidcrystal display screen 188, preferably with backlighting. Apiezoelectric speaker 190 and a headphone jack 192 provide audio output.Controls are provided for monitor power ON-OFF function (switch 194);display reset (switch 196), volume control function (dial 198); displaypressure calibration (normalize pressure display to read zero for “atrest” pelvic pressure level—switch 200); pressure threshold set switch414; and an operating mode selector switch 416. The manually selectableoperating modes include: Probe Power ON—active mode (wireless signalingwith vibrator power ON); Probe Power ON—passive mode (wireless signalingwith vibrator power OFF); and Probe Power OFF—sleep mode (battery save).

In the above described embodiments, ultra-low power radio frequency (RF)transmission is preferred for wireless high speed data transmission tothe transceiver 174. One-way or two-way wireless data communicationlinks may be implemented. Any short range, wireless RF datacommunication protocol, for example, Wireless USB, Bluetooth, Wi-Fi,Zigbee, or any standard, non-standard, or proprietary wireless protocolderivative of IEEE Standard 802.14.5 may be used for this purpose.

Optionally, the probe 10 can be fitted with a thermal transducer forsensing and providing an indication of pelvic temperature, for examplefor monitoring the onset of ovulation. Although the probe is sealed by aremovable handle in the exemplary embodiments, the probe and handle canbe hermetically sealed if desired.

Alternative embodiments of the transducer sleeve are shown in FIGS.16-23. These transducer sleeves each include one or more discretetransducer elements that are interconnected and embedded or enclosed inan annular sleeve body. In each sleeve embodiment, the impedance elementof the transducer strips is constructed with a selected one of theconventional transducer materials described above.

Referring to FIG. 16 and FIG. 17, a transducer sleeve 210 includesmultiple discrete transducer strips 212, 214, 216 and 218 embedded orenclosed within a flexible body 220 of a compressible polymercomposition, for example a closed cell polymer foam resin. Thetransducer strips extend along the length of the probe shaft, and areevenly spaced around the circumference of the shaft. The impedanceelements are interconnected in parallel circuit relation, collectivelyproviding a common impedance output signal Z.

Referring to FIG. 18 and FIG. 19, a transducer sleeve 230 includesmultiple discrete transducer bands 232, 234, 236, 238 and 240 embeddedor enclosed within a flexible body 242 of a compressible polymercomposition, for example a closed cell polymer foam resin. Thetransducer bands encircle the probe shaft, and are evenly spaced alongthe length of the shaft. The impedance elements are interconnected inparallel circuit relation, providing a common impedance output signal Z.

Referring to FIG. 20 and FIG. 21, a transducer sleeve 250 includes asingle elongated transducer strip 252 embedded or enclosed within aflexible body 254 of a compressible polymer composition, for exampleclosed cell polymer foam resin. The transducer strip is wrapped aroundthe probe shaft in a spiral pattern, and is secured thereto by anadhesive deposit. The impedance element is a continuous strip or body ofa selected one of the conventional transducer materials described above.

Referring to FIG. 22 and FIG. 23, a transducer sleeve 260 includesmultiple discrete transducer patches 262, 264, 266, 268 and 270 arrangedin a checker board pattern and embedded or enclosed within a flexiblebody 272 of a compressible polymer composition, for example closed cellpolymer foam resin. The transducer patches are evenly spaced apart in arectangular grid array throughout the sleeve body. The impedanceelements of the patches are interconnected in parallel circuit relation,providing a common impedance output signal Z.

An alternative wireless perineometer probe 300 is shown in FIGS. 24-27.In this embodiment, an air bladder 302 senses pelvic contractionpressure. The air bladder 302 is in the form of an elongated, annularsleeve having an outer sidewall 302A and an inner sidewall 302Bseparated by an annular air pressure chamber 304. The air bladder 302 isfitted around and attached to the shaft 46, preferably by an adhesivedeposit, and is coupled in fluid communication with a pressuretransducer module 306 via an inlet port 308 that intersects the shaftsidewall 46.

Although a double-walled bladder is illustrated, a single-wall bladder,hermetically sealed around the shaft 46 on its proximal and distal ends,can be substituted. Various medical grade rubber materials can be usedto fabricate the bladder. Preferably, the bladder is fabricated of aseamless, medical grade, low-modulus, non-latex, soft nitrilecomposition, having a sidewall thickness in the range of 4 mils-6 mils.

The air bladder 302 is pressurized through a check valve 310 and filltube 312 that are coupled in fluid communication with the annularbladder chamber 304 via an inlet port 316 that is formed through theshaft sidewall 46. Access to the check valve is provided by removing thehandle 50, and the bladder chamber is pressurized manually by a smallhand pump. The internal bladder pressure is communicated to thetransducer module 306 via a flow passage 318 that is connected in fluidcommunication with an internal bellows chamber 320 disposed within thetransducer module 306, as shown in FIG. 27.

A resilient membrane 322, attached across the bellows chamber, ismechanically coupled to a piezoelectric crystal transducer 324. As themembrane 322 deflects and extends, it applies mechanical stress acrossthe crystal in proportion to the magnitude of the air pressure in thebellows chamber. The electrical impedance Z of the piezoelectric crystaltransducer changes in proportion to the applied pressure, and thisimpedance signal is input to the transceiver module 80 via the signalconductors 98, 99. The piezoelectric crystal transducer 324 ispreferably comprises natural, reprocessed crystalline quartz with a longdischarge time constant operable in the charge mode as a dynamicpressure sensor.

The electrical equivalent or characteristic impedance Z of thepiezoelectric crystal 324 is a voltage source in series with acapacitance. The voltage source is the piezoelectric generator itself,and this source is directly proportional to the applied stimulus(pressure or strain). The transducer output voltage will follow theapplied pressure, and the output voltage is then buffered, filtered andscaled in the signal processor module 80 before it is converted to adigital data feedback signal. After being scaled and digitized, thepelvic contraction pressure signals are transmitted as wireless RFsignals to the hand-held monitor 170, as indicated in FIG. 15.

Referring now to FIGS. 28-33, an alternative perineometer probeembodiment 400 of the present invention is selectively operable in apassive reaction mode, in which audible, visual and tactile biofeedbacksignals proportional to pelvic muscle contractions are generated, and inan active vibrating mode in which therapeutic vibrations are applieddirectly to internal pelvic musculature with or without co-generation ofbiofeedback signals proportional to the strength of pelvic musclecontractions; and in a combination of both modes simultaneously. Theprobe 400 is constructed substantially the same as the embodiment shownin FIG. 2, but with the internal components rearranged to accommodate avibrator assembly 402.

The vibrator assembly 402 includes a DC motor M which drives a rotaryeccentric weight W. The motor M is energized by a supply voltage ofV_(D) that is derived from the battery 78 via a power supply module 404.The power module 404 also supplies DC operating power to the signalprocessor module 80 and frequency control module 410. The vibratorsupply voltage V_(D) is applied to the motor DC input terminals 406, 408through the variable frequency control module 410.

The output of the variable frequency control module 410 is applied toinput terminals 406, 408 of the motor M. The rotary speed (rpm) of motorM is directly proportional to the amplitude of the actuating voltageoutput from the frequency control module 410. In the preferredembodiment, the frequency of vibration (the rotary speed or rpm of theweight W) varies in direct proportion to the amplitude of the appliedvoltage V_(D), the amplitude of which is proportional to the appliedpelvic contraction pressure.

The frequency control module 410 has an input terminal 412 for receivingthe analog output signal 161 of the low noise amplifier 160 (FIG. 12).The output signal 161 is directly proportional to the pelvic contractionpressure sensed by the transducer 70. The frequency control module 410scales the analog output signal 161 and outputs a vibrator drivingvoltage V_(D) which varies from about zero volts DC to about 1.5 VDC.This driving voltage range corresponds to a vibration frequency rangefrom about 1 Hz corresponding with a nominal pelvic muscle pressureexerted on the probe under relaxed, “at rest” pelvic muscle condition,to about 100 Hz corresponding to a predetermined maximum sustainablepelvic muscle pressure exerted on the probe during a deliberate, besteffort pelvic contraction.

Although a linear relationship between motor RPM (vibration frequency)and contraction pressure (as represented by the vibrator drivingvoltage) is preferred, other functional relationships could be used aswell. For example, the relationship could be non-linear, in which casethe vibrator motor RPM could vary as an exponential function or as aparabolic function of the contraction pressure.

The output of the frequency control module 410 is normalized to zero byinserting the probe 400 into the vaginal cavity 12 as shown in FIG. 1,with the pelvic muscles 18, 20 relaxed. Then the operator manuallydepresses a set switch 414 that is located on the portable monitor 170(FIG. 13). The transceiver 174 transmits a control signal to the probethat establishes a threshold voltage level which is used as a referencein the speed control module 410 for establishing zero rpm output. Thiscorresponds to the nominal (at rest) pelvic pressure condition, asindicated in FIG. 33.

The DC motor M is preferably an ultra lightweight miniature DC motor,for example manufactured by Matsushita under Part Number V0296A, ratedfor a full output of 100 rpm at +1.5 VDC. Optionally, a piezoelectricvibrator may be substituted.

The perineometer probe 400 is operated in cooperation with the hand-helddisplay monitor 170, via wireless RF signaling. Referring to FIG. 13 andFIG. 32, the portable monitor 170 is equipped with a two-waytransmitter-transceiver 174 for sending RF wireless mode selectioncommand signals 412 to the perineometer probe 400. The portable monitor170 receives RF wireless biofeedback signals 176 from the perineometerprobe transmitter 164 for providing a visual display of the pelvicpressure waveform 186 and audible feedback signals 187 in response topelvic contractions, as shown in FIG. 13 and FIG. 15.

The motor-driven vibrator assembly 402 produces therapeutic tactilevibrations while pelvic exercise is underway. According to a pelvicmuscle strengthening and conditioning mode of operation, the vibrationcontrol circuitry increases the vibration frequency in proportion to anincrease in the magnitude of the sensed contraction pressure. In apelvic muscle relaxation conditioning mode of operation, the vibrationcontrol circuitry reduces the vibration frequency of vibration inproportion to a reduction in the sensed contraction pressure.

Because the probe 400 remains inserted during exercise and the sensor 70is in intimate contact with the pelvic muscles, the body of the probecan be sensed directly and felt by the patient as the pelvic muscles arecontracted against it, thus providing a passive tactile biofeedbacksignal either alone or in combination with active, vibration-inducedtactile biofeedback signals. Multiple modes of operation can be selectedmanually by depressing the ,ode selection switch, either (a) thepassive, reaction mode, in which audio/visual biofeedback signalsproportional to pelvic muscle contractions are generated, or (b) anactive, vibrating mode in which vibration therapy is applied directly tointernal pelvic musculature, with co-generation of vibration-inducedtactile biofeedback signals proportional to the strength of pelvicmuscle contractions, or (c) a combination of both modes simultaneouslymay be selected.

The desired operating mode is selected by the patient by depressing amembrane mode selector switch 416 on the portable monitor 170. Selectionof the active, vibrating mode initiates the transmission of a wirelesscommand signal 176 from the monitor 170 to the probe 400. The commandsignal is decoded in the transceiver 164, which outputs a control signal412 (FIG. 15) that enables operation of the vibrator 402.

The perineometer encourages pelvic muscle reeducation and strengthening,by (1) giving direct tactile sensory feedback, both passive andvibration induced, to the patient during exercise which allows thepatient to identify the pelvic floor muscles and confirm that the probeis properly engaged; (2) developing muscle strength and endurance due tothe work required of the muscles to contract and relax against thereaction probe, thereby developing muscle memory; (3) providing audibleand/or visual sensory feedback simultaneously with vibration-inducedtactile sensory feedback that is directly related to performance duringexercise, thus instilling patient confidence that the probe is beingused properly and that the exercises are having the desired trainingeffect; and (4) promoting strong pelvic muscle contraction and normalmuscle relaxation in response to passive tactile biofeedback signals andvibration-induced tactile biofeedback signals that are communicateddirectly by internal contact, and by wireless biofeedback signals thatare communicated in real time to the patient via a portable displaymonitor.

1. An instrument for training and rehabilitating a patient's pelvicmuscles comprising a probe configured for insertion into a pelvic cavityand including at least one sensor for dynamically sensing a forceapplied to the probe by contraction of the pelvic muscles, vibratorapparatus disposed in the probe for imparting mechanical vibrationsagainst the pelvic muscles, and a control circuit coupled to the sensorand the vibrator apparatus for selectively operating the traininginstrument in a passive, reaction mode in which passive tactile feedbacksignals are produced with co-generation of biofeedback signalsproportional to pelvic muscle contractions, and in an active, vibratingmode in which vibration therapy is applied directly to internal pelvicmusculature; and in a combination of both modes simultaneously.
 2. Aninstrument for training and rehabilitating a patient's pelvic floormuscles according to claim 1, wherein: the sensor comprises a variableimpedance element capable of exhibiting a change in electrical impedancein response to pressure forces applied to the probe; and the controlcircuit comprises an electronic circuit module enclosed within the probeand electrically coupled to the variable impedance element fortransmitting wireless feedback signals in response to pelvic contractionforces applied to the probe.
 3. Apparatus for training a patient'spelvic floor muscles, comprising in combination: a probe receivablewithin a patient's pelvic cavity for engaging pelvic muscles, the probecontaining a transducer capable of exhibiting a change in electricalimpedance in response to pelvic muscle contractions against thetransducer; a signal processor circuit contained in the probe andelectrically coupled to the transducer for transmitting a wireless radiofrequency signal containing feedback information related to theelectrical impedance of the transducer; a portable monitor including aradio frequency transceiver for transmitting and receiving the wirelessfeedback signal and an indicator device coupled to the transceiver fordisplaying a visual representation of feedback information contained inthe wireless signal; vibrator apparatus disposed in the probe forimparting mechanical vibrations against the pelvic floor muscles; and acontrol circuit electrically coupled to the transducer and to thevibrator apparatus for stimulating the pelvic floor muscle withmechanical vibrations at a frequency that is proportional to themagnitude of the sensed pelvic muscle contraction force.
 4. A method fortraining and rehabilitating a patient's pelvic floor muscles comprisingthe steps: inserting a probe into a pelvic cavity; selectivelycontracting and relaxing the patient's pelvic floor muscles against theprobe; producing a signal proportional to the force applied by thepelvic floor muscles against the probe; selectively operating the probein a passive training mode or in an active training mode, and forpassive mode operation, (a) imparting internal passive tactile feedbacksignals to a patient in response to contraction of the pelvic floormuscles against the probe; and for active mode operation, (b) impartingmechanical vibrations against the pelvic floor muscles at a vibrationfrequency that is proportional to the pelvic muscle contraction forceapplied against the probe; transmitting to a portable monitor abiofeedback signal that contains information related to the forceapplied against the prove during pelvic muscle contractions; andreceiving the biofeedback signal on a portable monitor and displayingthe signal in a format that can be observed or heard by the patientwhile a training exercise is underway.
 5. The method for training andrehabilitating a patient's pelvic floor muscles as set forth in claim 4,including the steps: providing a probe having a transducer capable ofexhibiting a change in electrical impedance in response to pelviccontractions applied to the transducer; transmitting a wireless radiofrequency signal containing feedback information related to theelectrical impedance of the transducer; producing a tactile feedbacksignal in response to the pelvic contractions; communicating the tactilefeedback signal directly to the patient via transmission of reactionforces through the pelvic muscles engaged about the probe; communicatingthe wireless radio frequency signal to a portable monitor; anddisplaying a visual representation of feedback information contained inthe wireless signal on the portable monitor so that it can be observedby the patient while a training exercise is underway.
 6. A method ofexercising and training pelvic floor muscles according to claim 4,further comprising the step: allowing the patient to sense internaltactile feedback signals and mechanical vibrations while observing thevisual representation display on the portable monitor during contractionof pelvic floor muscles against the probe.
 7. A method of exercising andtraining pelvic floor muscles according to claim 4, further comprisingthe step: increasing the vibration frequency in direct proportion toincrease in the magnitude of the sensed contraction force during theactive operating mode.
 8. A method of exercising and training pelvicfloor muscles according to claim 4, further comprising the step:reducing the vibration frequency in direct proportion to decrease in themagnitude of the sensed contraction force in a pelvic muscle relaxationtraining mode of operation.
 9. A method for training and rehabilitatinga patient's pelvic floor muscles comprising the steps: inserting a probeinto a pelvic cavity of a patient; maintaining the probe in intimatecontact with pelvic floor muscles as the pelvic muscles are contractedagainst the probe; sensing the strength of pelvic contractions by directtactile sensation to the patient in response to engagement of pelvicfloor muscles against the probe; producing a signal proportional to thepressure force applied by the pelvic floor muscles against the probe;generating a biofeedback signal that is a function of the pressure forcesignal and communicating the biofeedback signal to a portable monitor;imparting mechanical vibrations against the pelvic floor muscles at afrequency that is proportional to the magnitude of the pressure forceapplied by the pelvic floor muscles against the probe; and selectivelycontracting and relaxing the patient's pelvic muscles against the probewhile the patient selectively experiences (a) vibration-induced tactilebiofeedback with or without audible or visual biofeedback monitoring, or(b) passive tactile biofeedback with or without audible or visualbiofeedback monitoring, during a training exercise.
 10. A method forpelvic floor muscle conditioning comprising the steps of (a) inserting aprobe containing a vibrator and a force sensor into a pelvic cavity; (b)contracting the pelvic floor muscle against the probe; (c) sensing themagnitude of pelvic floor muscle contraction forces applied against theprobe; and (d) stimulating the pelvic floor muscle with mechanicalvibrations occurring at a frequency that is proportional to themagnitude of the pelvic muscle contraction force.
 11. The method forpelvic floor muscle conditioning according to claim 10, including thestep of controlling the vibrations to occur at a frequency that issubstantially directly proportional to the magnitude of the pelvicmuscle contraction force.
 12. The method for pelvic floor muscleconditioning according to claim 10 including the steps of increasing thevibration frequency from about 1 Hz corresponding with a nominal pelvicmuscle force exerted on the probe under “at rest” relaxed pelvic musclecondition, to a vibration frequency of about 100 Hz corresponding to apredetermined maximum pelvic muscle force exerted on the probe during asustained, best effort pelvic muscle contraction.
 13. The method as setforth in claim 10, including the step: selectively contracting andrelaxing the patient's pelvic muscles against the probe while thepatient selectively experiences either (a) vibration-induced tactilebiofeedback with or without audible or visual biofeedback monitoringduring an active mode training exercise, or (b) passive tactilebiofeedback with or without audible or visual biofeedback monitoringduring a passive mode training exercise.
 14. A method of exercising andtraining pelvic floor muscles according to claim 10, further comprisingthe step: reducing the vibration frequency substantially in directproportion to decrease in the magnitude of the contraction force duringa pelvic muscle relaxation training mode of operation.
 15. A method ofexercising and training pelvic floor muscles according to claim 10,further comprising the step: selectively operating the probe in apassive reaction mode, in which audible, visual and tactile biofeedbacksignals proportional to pelvic muscle contractions are generated, or inan active vibrating mode in which therapeutic vibrations are applieddirectly to internal pelvic musculature with or without co-generation ofbiofeedback signals proportional to the strength of pelvic musclecontractions; or in a combination of both modes simultaneously.
 16. Amethod of exercising and training pelvic floor muscles according toclaim 10, further comprising the step: selectively contracting andrelaxing the patient's pelvic muscles against the probe; co-generatingbiofeedback signals proportional to the strength of the pelvic musclecontractions; transmitting the biofeedback signals to a portable monitorthat can be observed by the patient; receiving the biofeedback signalsin the portable monitor and displaying the biofeedback signals in aformat that can be viewed or heard by the patient while a trainingexercise is underway; and selectively operating the probe in a passivereaction mode in which the probe reacts the pelvic contraction and thusprovides passive tactile feedback signals that are experiencedinternally while by the patient is simultaneously observing biofeedbacksignal displays on the portable monitor.